A protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment for Normal Eating) intervention compared with 5x1 DAFNE: A lifelong approach to promote effective self-management in adults with type 1 diabetes

Elizabeth Coates, Stephanie Amiel, Wendy Baird, Julia Lawton, David Rankin

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment for Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short-term (manifest by falls in HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behaviour change techniques, technology and longer-term structured support from healthcare professionals. Methods and analysis: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in NHS secondary care hospitals in the United Kingdom. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c (glycated haemoglobin) and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation. Ethics and dissemination: Ethics approval was granted by South West – Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14th May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.
Original languageEnglish
Pages (from-to)e040438
JournalBMJ Open
Volume11
Issue number1
DOIs
Publication statusPublished - 18 Jan 2021

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